Disposable device for applying mouth to mouth resuscitation

ABSTRACT

A disposable device for applying mouth to mouth resuscitation, comprising a prophylactic face mask portion for the person applying artificial respiration and a tubular member for channeling air into the mouth of the victim to be revived and for preventing reverse flow of fluids and air expelled or exhaled by the victim. The device is constructed entirely of flat and flexible materials to allow folding and packaging of the device in a compact, flat condition, and is adapted to be discarded after a single use.

United States Patent 1191 Sherman 1 1 Apr. 9, 1974 [54] DISPOSABLE DEVICE FOR APPLYING 3,057,347 8/1962 McGee 128/1455 MOUTH o MOUTH RESUSCITATION green t etmer Inventor: g q J- Sherman, 401 29th 3,508,543 4/1970 Aulicono 128/1455 ak and, Calif. 94612 [22] Filed: Apr. 17, 1972 Primary Examiner-Richard A. Gaudet Assistant Examiner-Lee S. Cohen [21] Appl' 244,782 Attorney, Agent, or Firm-Harris Zimmerman Related US. Application Data [63] Continuation-impart of Ser No. 859,485, 'Sept. 9, [57] ABSTRACT 1969' A disposable device for applying mouth to mouth re- [52 11.5. C1. 128/1455 sPscitation' Comprising T F i non for the person applymg artificial resplratlon and a [51] Int. Cl A621) 7/00 b b f h h h f [58] Field of Search 128/1455, 145.6, 145.7, tfi ig ff g g gg g j gigs f f sg g 128/1458 351 flow of fluids and air expelled or exhaled by the victim. The device is constructed entirely of flat and flex- [56] f gfi g gzi ible materials to allow folding and packaging of the device in a compact, flat condition, and is adapted to 3,124,]24 3/l964 CIOSS, 128/1455 be discarded after a sin ]e use 2,857,911 10/1958 Bennett 128/147 g 2,995,131 8/1961 Elan 128/1455 4 Claims, 2 Drawing Figures DISPOSABLE DEVICE FOR APPLYING MOUTH TO MOUTH RESUSCITATION REFERENCE TO PRIOR APPLICATION The present application is a continuation-in-part application of my'prior application Ser. No. 859,485, filedSept. 9, 1969, and now abandoned.

BACKGROUND OF THE INVENTION The invention relates to devices for facilitating the administration, of artificial respiration by mouth to mouth resuscitation. More particularly, the present invention relates to resuscitators which. are collapsible and disposable.

Mouth to mouth resuscitation is a method of artificial respiration which is' well known and highly recommended in view of several inherent advantages over other forms of artificial respiration. In fact, mouth to mouth resuscitation has been held to be the most practical method of emergency ventilation by the Ad I-Ioc Committee on Artificial Respiration of the National Academy of Sciences and the National Research Council. The advantages of this method are that it provides a method by which to pressurize and inflate a victim s lungs directly. In addition, the volume flow of air, pressure and timing are inherently correct since the rescuer administers respiration in accordance with his own natural breathing rate. Also, mouth to mouth resuscitation is by far, the least tiring and can therefore be easily maintained for extended time periods with a constant rhythm.

There are, however, several problems associated with the application of this form of artificial respiration without aids. The principal difficulty is due to the fact that many regard the personal contact called for as repulsive or unesthetic. Indeed, the victim may suffer from contagious diseases which could be readily transmitted to the rescuer. Furthermore, the victim will often expel fluids or other matter obstructing his air passages. This invariably causes at least an interruption of the regular breathing rhythm with which the rescuer applies resuscitation. A rescuer may also become too nauseated to be able to continue his efforts.

TI-IEIRIOR ART The problems referred to above have been recognized previously and a variety of resuscitators have been devised which will protect the operator and improve the effectiveness of this method of artificial respiration. The majority of prior art devices comprise some means for maintaining some distance and separation between the faces of the rescuer and the victim. The most common feature is a rigid tube extending between a mouthpiece for the operator and a terminal portion which engages the victims mouth. Another common feature is to provide two relatively stiff curved face plates which fit over and cover thelower face portion'of the victim and rescuer respectively. Those devices which include a provision for preventing backstreaming of regurgitated and exhaled materials exhibit unidirectional valves of .various construction built into the rigid tube which channels the air from the operator to the victim. Most of these devices are effective aids for administering artificial respiration. However, their use has not become widespread. The principal reason for the lack of general acceptance is thought to be simply due to the bulkiness of these instruments. Even though many of the resuscitators can be disassembled, the package of rigid parts is still too bulky and inconvenient to carry, and discourages their use by all but professional rescue teams. Another problem with the prior art instruments is due to the relative sophistication of the valves which increases the costs thereof and impairs their reliability.

Devices typical of such prior art are disclosed in Detmer, US. Pat. No. 3,303,845, Green, Pat. No. 3,137,293 and Elam et aL, Pat. No. 2,995,131. None of these devices are constructed entirely of flexible sheets such as thin rubber or suitable plastic so as to permit the person administering artificial respiration to feel the mouth of the victim to thereby determine whether his exhaled breath is properly passing to the victim.

Finally, there are also some practical difficulties which have not been adequately solved. When air is forcedinto the victim, it is necessary to close the victims nose and the area around the victims lips. The nose is always closed by pressing the victims nostrils together. The area around the victims lips, however, must be closed by contact with a suitable mechanical sealing member on the resuscitator. The operator is therefore not able to directly feel and correct for a leak as effectively as when there is personal contact with the victim. After each breath, the victim is allowed to exhale. In the case of devices which have no valves to allow exhalation, the seal around his mouth must be broken, particularly if the victims nasal passages are not clear. Accordingly, even in the case of smaller, less sophisticated instruments, one hand of the operator is required to help manipulate the resuscitator. The larger instruments must nearly always be hand-held. Accordingly, a major object of the present invention is to provide a low cost, disposable resuscitator which shields the operator from direct, skin to skin contact with the victim as well as against the victims exhaled and regurgitated materials, but which can also be constructed in such a manner that it can be folded into a flat, miniaturized package and conveniently carried by members of the public as well as persons with special rescue duties.

Another important object of this invention is to provide a resuscitator which can be operated without the use of hands, i.e., so as to leave both hands of the operator free to apply pressure to the victims nostrils and hold the victims jaws and head in the proper position, while allowing the rescuer to form a seal around the mouth of the victim with his own lips and thereby feel the quality of the seal being made.

A further object of the invention is to provide a device as above described which may be simply constructed from any suitable inexpensive flexible material, thereby permitting it to be discarded after a single use.

SUMMARY OF THE INVENTION I have realized the above objects by devising a resuscitator which comprises a face mask portion made from a very thin, flexible rubber or plastic material which extends over the mouth area of the person administering artificial respiration. Connected to the periphery of a central opening in the face mask portion is a tubular extension of a similar thin and flexible rubber or rubberlike material which is placed into the mouth of the victim. By choosing materials of a suitable thickness and quality I also provide the operator with the ability to intimately feel the patients face and lips so that he can effectively control the contact made with the victim by motion of head and lips alone. By providing a strap or similar means for securing the resuscitator to the operators face, he is able to use both hands as needed to facilitate his rescue efforts. Both the face mask and tubular extension are made of impermeable materials which afford the necessary protection against transmission of germs and other undesirable materials. Backstreaming of fluids into the mouth of the rescuer is surprisingly effectively prevented by making the tubular extension of such materials as I have indicated, since the relation of the size of the surface area and the flexibility of the tube will cause it to collapse and seal rather than transmit materials from the victim to the operator. The quality of this seal is rendered even more effective by the additional features discussed below.

Further details of the invention will be described with reference to the drawings, of which FIG. 1 is a perspective view of one embodiment of the invention, and

FIG. 2 is a side elevational view, partly in cross section, of a preferred embodiment including additional safeguards for impeding the flow of fluids and air from the victim to the operator.

DESCRIPTION OF THE PREFERRED EMBODIMENTS The general design of my resuscitator is shown in FIG. 1. The numeral 11 refers to the face mask portion of the resuscitator, which overlies the mouth of the operator and which likewise overlies the mouth of the victim. As shown, the face mask may be of oval shape, with a major diameter between about 5 and 7 inches, extending from the left to the right cheek of the operator. The minor diameter is about 4 to 5 inches, so that the face mask can be positioned to extend from just under the nose to the chin. The face mask provides a central opening 12 which is positioned to become aligned with the operators mouth. The dimensions of opening 12 are intended to be less than the area subtended by the operators open mouth, i.e. about h to 1 inch in diameter. It will be realized that the properly positioned face mask will therefore cover the operators lips as well as the portion of his face adjacent thereto.

The face mask portion is generally made of a material which is impermeable, so as to be impenetrable by moisture, air, and microorganisms. In addition, the material must be thin and flexible, that is to say, it should conform to the contour of the operator's face and enable him to feel the victim's skin. These requirements are satisfied by plastic films or sheets of thicknesses from I up to mils in thickness. More specifically suitable materials include impermeable film-forming thermoplastics such as nylon, polyethylene, polypropylene, polyvinyl chloride, polyvinyl acetate, and soft cellulose acetate. Polytetrafluoroethylene and polytrifluoroethylene could of course also be used, however, the latter materials are relatively expensive. The preferred thicknesses employed are about 2 5 mils so that the material will stretch, thus providing the best possible leak-tight fit. Greater thicknesses as indicated can be employed; however, such resuscitators require greater care in positioning. A material which is also especially suitable is very thin rubber sheet, about 2 5 mils thick, since rubber readily stretches to conform to the face and lip contours of the operator and the victim. As above mentioned, the device is preferably disposable, so cost is a consideration in the selection of material.

The numeral 13 refers to a tubular, hose-like extension which is hermetically joined or formed integrally with the face mask 11 along the periphery of opening 12. As shown, the tube 13 may be cylindrical, of equal diameter to the opening 12, with an overall length of about 2 to 3 inches. Tube 13 should be constructed of the same materials as face mask 11; however, the thickness of the material should not be more than about 5 mils, in order to ensure that the tube immediately collapses when the victim begins to exhale. This also permits the tube to be folded flat against the mask and the mask and tube subsequently further folded to define a flat package.

To administer artificial respiration, the rescuer secures the mask over his face by means of a flexible strap 14, which is made of rubber, rubberized fabric or similar elastic, and attached to the outer edge of the mask in any suitable manner.

FIG. 2 illustrates a preferred embodiment of the invention, comprising face mask portion 21 having central opening 22 to which breathing tube 23 is attached. The construction and function of the aforesaid elements and the strap 24 is generally the same as set forth in the description of FIG. 1 above. However, the breathing tube shown is of a tapered configuration, so that the end 26 which extends into the patients mouth provides a reduced cross sectional area. This feature further reduces the probability that the victims exhalations and fluids will enter the resuscitator, before the central portion of the tube collapses under the pressure exerted thereon by the exhalations.

The tapered construction is therefore preferred, and could be used without the additional internal safeguards which are in the form of a plurality, e.g., two or more elongated, preferably tapered strips 28 of plastic or rubber. These strips are attached to the mask or to the inside surface of tube 23 near the periphery of opening 22. Each strip is disposed adjacent to or actually overlapping with the next. The strips freely extend along the inside of tube 23 to a point near the tapered end 26. Any air or fluid entering tapered end 26 will tend to blow back the loose ends 29 of the strips 27, causing them to essentially block the tube and deny passage of the air or fluid into the mouth of the rescuer. However, the strips readily unroll or unfold when the rescuer again forces air into the victim's lungs and do not interfere with this latter operation.

The resuscitator described herein may be satisfactorily made by a variety of conventional plastic or rubber manufacturing techniques. More specifically, resuscitator embodiments described thus far may be made as an integral unit comprising the face mask and breathing tube in one piece. Suitable means for fastening the strap 14, such as loops 15, may also be provided as an integral part of the face mask portion. Specific techniques which can be employed are molding, also blow molding to a suitable die, followed by trimming the ends 26.

In view of the thinness of the face mask portion, it is desirable to provide an outer reinforcing rim 16 as shown in FIGS. 1 and 2. This rim or border may be made of the same plastic or rubber material as the mask itself, integrally manufactured therewith. by molding the outer edges to a greater thickness. It is also possible to employ a flexible ring, such as a thermoplastic or rubber O-ring 17, and join the plastic material thereto, which may also be'done in a subsequent operation involving thermal bonding or welding, or other conventional techniques. It should be noted that the outer rim may also be strengthened by joining the face mask material to a wire hoop, such as by folding the edge of the sheet over the hoop back on itself and welding or adhesively fastening the edge thereto.

While the face mask 21 and breather tube 23 may be integral, the preferred construction shown in FIG. 2 exhibits plastic, rubber or metal O-ring 29 which provides a well defined mouth piece for the rescuer, always maintained in an open position by the O-ring. This 0- ring is joined to the end of tube 23 by techniques similar to those discussed supra and the composite is then joined to the periphery of opening 22 in the face mask. It will be appreciated that a face mask and breather tube made of different materials and thicknesses optimized for the individual functions of these elements are advantageously employed and made in conjunction with the latter construction and method of manufacture.

An important advantage of the present resuscitator is its low cost, which makes the item disposable after use. However, most importantly, the resuscitator can be folded into a package about one-fourth inch thick, 1 inch wide, and about 3 inches long, i.e. about the size of a large Band-aid, which can be conveniently and inconspicuously carried by anyone.

Due to the flexibility of the device, it will be appreciated that the face mask portion can be placed over the victims face and secured thereto by the strap 14, and with the tube extending into the victims mouth. This arrangement permits the operator to move his head without pulling the tube from the victims mouth.

Having thus described my invention, it should be noted that the description was intended to be directed principally to what may be regarded as specific preferred embodiments of the invention, and that many modifications may be made within the skill of the art -without departing from the spirit and scope of the invention, which is therefore intended to be limited only by the scope of the following claims.

I claim:

1. A device for applying mouth to mouth resuscitation by a rescuer to a victim, consisting essentially of: shield means for directly engaging the lips of the rescuer and victim respectively on its opposite sides during mouth to mouth resuscitation and being constructed of a thin, flexible sheet material substantially impervious to air, moisture and microorganisms, said sheet being of a size sufficient to cover at least the area subtended by the open mouth and adjacent facial portions of a normal adult person, said sheet defining an essentially centrally located aperture therethrough, said aperture subtending an area of sufficient size to allow a normal adult rescuer to exhale therethrough during the mouth to mouth resuscitation, said sheet being foldable into a flat rectangular package for storing wholly within the mouth of the victim and permitting the flow of rescuer air and other fluid from said aperture into the victims mouth by inflating and preventing the flow of victim air and other fluid through said aperture in the reverse direction by collapsing, said valve means being a normally collapsed open-ended tubular member of a thin, flexible sheet material substantially impervious to air, moisture and microorganisms, said tube having a length sufficient to extend into the mouth of the victim, one axial end of said tube being hermetically joined to said sheet around the periphery of said aperture by means to generally hold said tube open at said one end, and said tube being readily collapsible and foldable flat against said sheet for storage.

2. The device of claim 1 further defined in that said tubular member is tapered along its longitudinal axis with its maximum diameter adjacent said aperture.

3. The device of claim 1, wherein said tubular member has a wall thickness of not more than 5 mils. and a length within the range of 2 to 3% inches.

4. A device for applying mouth to mouth resuscitation by a rescuer to a victim, comprising: a sheet of a thin, flexible material substantially impervious to air, moisture and microorganisms, said sheet being of a size sufiicient to cover at least the area subtended by the open mouth and adjacent facial portions of a normal adult person; said sheet defining an essentially centrally located aperture therethrough, said aperture subtending an area of sufficient size to allow a normal adult to exhale therethrough when said face mask is positioned over the lower portion of the face of said adult; an open-ended tubular member of a thin, flexible material substantially impervious to air, moisture and microorganisms, having a length sufficient to extend into the mouth of the person to whom artificial resuscitation is to be applied; one end of said tubular member being hermetically joined to the periphery of said aperture by means to generally hold said tube open at said end; said tubular member extending outwardly from said one end and said sheet in its operative position and being readily collapsible and foldable flat against said sheet in its inoperative storage position; said sheet and member being further foldable into a flat rectangular package for storage; means for securing said sheet over the face of a normal adult with said aperture and tubular member aligned with said victims mouth; said tubular member including one way check valve means permitting the flow of air and other fluid from said one end to the other end by inflating and preventing the flow of air and other fluid from the other end to said one end by collapsing its walls inwardly together at said other end, whereby air and other fluid will only pass from the rescuer to the victim through said tubular member; and said valve means being provided with a plurality of overlapping elongated strips of a thin and flexible material, each having one end thereof secured to said device near the periphery of said aperture and distending freely within said tubular member and the other end thereof terminating adjacent the distal end of said member.

ll l It t t 

1. A device for applying mouth to mouth resuscitation by a rescuer to a victim, consisting essentially of: shield means for directly engaging the lips of the rescuer and victim respectively on its opposite sides during mouth to mouth resuscitation and being constructed of a thin, flexible sheet material substantially impervious to air, moisture and microorganisms, said sheet being of a size sufficient to cover at least the area subtended by the open mouth and adjacent facial portions of a normal adult person, said sheet defining an essentially centrally located aperture therethrough, said aperture subtending an area of sufficient size to allow a normal adult rescuer to exhale therethrough during the mouth to mouth resuscitation, said sheet being foldable into a flat rectangular package for storage; and collapsible tube check valve means for extending wholly within the mouth of the victim and permitting the flow of rescuer air and other fluid from said aperture into the victim''s mouth by inflating and preventing the flow of victim air and other fluid through said aperture in the reverse direction by collapsing, said valve means being a normally collapsed open-ended tubular member of a thin, flexible sheet material substantially impervious to air, moisture and microorganisms, said tube having a length sufficient to extend into the mouth of the victim, one axial end of said tube being hermetically joined to said sheet around the periphery of said aperture by means to generally hold said tube open at said one end, and said tube being readily collapsible and foldable flat against said sheet for storage.
 2. The device of claim 1 further defined in that said tubular member is tapered along its longitudinal axis with its maximum diameter adjacent said aperture.
 3. The device of claim 1, wherein said tubular member has a wall thickness of not more than 5 mils. and a length within the range of 2 to 3 1/2 inches.
 4. A device for applying mouth to mouth resuscitation by a rescuer to a victim, comprising: a sheet of a thin, flexible material substantially impervious to air, moisture and microorganisms, said sheet being of a size sufficient to cover at least the area subtended by the open mouth and adjacent facial portions of a normal adult person; said sheet defining an essentially centrally located aperture therethrough, said aperture subtending an area of sufficient size to allow a normal adult to exhale therethrough when said face mask is positioned over the lower portion of the face of said adult; an open-ended tubular member of a thin, flexible material substantially impervious to air, moisture and microorganisms, having a length sufficient to extend into the mouth of the person to whom artificial rEsuscitation is to be applied; one end of said tubular member being hermetically joined to the periphery of said aperture by means to generally hold said tube open at said end; said tubular member extending outwardly from said one end and said sheet in its operative position and being readily collapsible and foldable flat against said sheet in its inoperative storage position; said sheet and member being further foldable into a flat rectangular package for storage; means for securing said sheet over the face of a normal adult with said aperture and tubular member aligned with said victim''s mouth; said tubular member including one way check valve means permitting the flow of air and other fluid from said one end to the other end by inflating and preventing the flow of air and other fluid from the other end to said one end by collapsing its walls inwardly together at said other end, whereby air and other fluid will only pass from the rescuer to the victim through said tubular member; and said valve means being provided with a plurality of overlapping elongated strips of a thin and flexible material, each having one end thereof secured to said device near the periphery of said aperture and distending freely within said tubular member and the other end thereof terminating adjacent the distal end of said member. 